Weight loss · Weekly shot
Dulaglutide
FDA approvedfor another use4.6 kg weight loss on 4.5 mg
FDA Approved for type 2 diabetes · Controlled trials for this use · 36 weeks · Frias 2021
FDA approved · Prescribed by a doctor, made by a manufacturer.
Bottom line
Reliable diabetes drug. Real cardiovascular benefit. Modest weight loss compared to its newer cousins.
- Also called
- Trulicity® · LY2189265 · GLP-1(7-37)-IgG4 Fc fusion · Eli Lilly and Company
- Category
- Biologic — GLP-1-Fc Fusion Receptor Agonist
- Molecular Weight
- ~63 kDa dimer
- Class
- GLP-1 receptor agonist (long-acting)
- Half-life
- ~5 days
- Route (studied)
- SubQ (people)
- Route (sold)
- SubQ single-dose pens (Trulicity)
- FDA Status
- Approved 2014 (T2D); 2020 (CV risk reduction)
- Approved Doses
- 0.75, 1.5, 3.0, 4.5 mg weekly
- Pivotal Trials
- AWARD 1–11, REWIND
- Black Box Warning
- Thyroid C-cell tumors (rodent)
- Manufacturer
- Eli Lilly & Company
- Cost & Access
- Branded prescription only
Also for weight loss
- Weight loss · Daily shotExenatideGLP-1Byetta, the diabetes shot copied from Gila monster venom. Obese, no diabetes: 3.3% of weight beyond placebo.Controlled trialsFDA approvedfor another useChecked Oct 17
- Weight loss · Daily shotPramlintideAmylinApproved in 2005 for diabetics on insulin: three shots a day, boxed warning. Not a weight-loss drug.Controlled trialsFDA approvedfor another useChecked Oct 18
- Weight loss · Weekly shotRetatrutideGLP-1Lilly's triple-hormone shot, unapproved; gray-market copies sell anyway. Phase 3: 25.0% loss at 80 weeks.Controlled trialsGray marketChecked Oct 12
What does it do? Drops blood sugar and nudges off 2–5 kg in trials (Nauck et al., 2014; Frias et al., 2021). The GLP-1 playbook: more insulin when glucose is up, less glucagon and slower stomach emptying; decreased appetite is a common side effect (Trulicity label).
Who uses it? Adults and children 10 and older with type 2 diabetes, on a once-weekly pen (Trulicity label). Since 2020, also approved for cardiovascular-risk reduction (Trulicity label; Drugs@FDA). Mostly stayed in the diabetes lane while semaglutide and tirzepatide took over obesity.
Does the evidence hold up? Yes. Randomized trials of it alone and with other diabetes drugs back the diabetes approval (Trulicity label). The REWIND trial in 2019 cut major cardiovascular events by 12% (HR 0.88) over a median 5.4 years in 9,901 adults with type 2 diabetes (Gerstein et al., 2019).
Bottom line? Reliable diabetes drug. Real cardiovascular benefit. Modest weight loss compared to its newer cousins.
Dosing from the Literature
Published for fat loss: the diabetes label's 0.75–4.5 mg a week; weight fell as a side result in those trials. Not published: a weight-loss trial in people without diabetes.
The doses below are from the FDA label: each is injected under the skin once a week, at any time of day, with or without food, from a pre-filled single-dose pen, with nothing to reconstitute (Trulicity label).
| Indication | Starting Dose | Maintenance Dose | Notes |
|---|---|---|---|
| Type 2 diabetes — glycemic control | 0.75 mg SubQ weekly | May be increased to 1.5 mg weekly after 4 weeks for additional glycemic control | FDA label (Trulicity, 2026): adults with type 2 diabetes, alongside diet and exercise. In the label's trials of 0.75 and 1.5 mg, people stayed on their starting dose for the whole trial. |
| Type 2 diabetes — additional glycemic control | Increased to 3.0 mg weekly from 1.5 mg after ≥4 weeks | Increased to 4.5 mg weekly from 3.0 mg after ≥4 weeks if needed | FDA label (Trulicity, 2026): adults; 1.5 mg steps after at least 4 weeks on the current dose, to a 4.5 mg maximum, stepped up to reduce the risk of stomach and bowel side effects. AWARD-11 gave 3.0 or 4.5 mg (vs 1.5 mg), reached in 4-week steps from 0.75 mg, to 1,842 adults with type 2 diabetes on metformin (Frias et al., 2021). |
| T2D with established CVD or CV risk factors | 0.75 mg weekly starting dose | Same steps as above; REWIND tested 1.5 mg weekly | FDA label (Trulicity, 2026): one dosing scheme for both indications, here adults with type 2 diabetes and established cardiovascular disease or multiple risk factors. REWIND gave 1.5 mg once weekly to 9,901 adults aged 50 or older with type 2 diabetes and a previous cardiovascular event or risk factors (Gerstein et al., 2019). |
| Pediatric T2D (age ≥10) | 0.75 mg weekly | May be increased to 1.5 mg weekly, the maximum for children, after at least 4 weeks if more glycemic control is needed | FDA label (Trulicity, 2026): children 10 and older with type 2 diabetes. Approved for them in November 2022 (Drugs@FDA), on a 26-week trial in 154 children (Trulicity label). |
| Renal impairment | No dose adjustment | Same as above | FDA label (Trulicity, 2026): no dose adjustment for kidney impairment, including end-stage renal disease, with caution advised in end-stage disease. AWARD-7 gave 0.75 or 1.5 mg to 577 adults with type 2 diabetes and moderate-to-severe chronic kidney disease (Tuttle et al., 2018). |
| Hepatic impairment | No specific adjustment | Same as above | FDA label (Trulicity, 2026): no clinically relevant change in dulaglutide levels, but limited clinical experience in mild, moderate or severe hepatic impairment, with caution advised in all three. |
Dulaglutide is a prescription pharmaceutical; its dose is the prescribing clinician’s call. Each single-dose pen delivers one fixed dose and is used once. The label lists the abdomen, thigh or upper arm, with the site rotated each dose, and its Medication Guide says not to inject into a muscle or vein (Trulicity label).
→ Calculator — vial-to-syringe math
What It Is
Dulaglutide (brand name Trulicity; development code LY2189265) is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist biologic developed by Eli Lilly and Company. Chemically, it is a homodimer of two identical chains, each consisting of a modified human GLP-1(7-37) analog linked via a small peptide spacer to a modified human IgG4 Fc heavy-chain fragment. The GLP-1 portion carries substitutions (Gly8, Glu22, Gly36) that confer resistance to DPP-4 cleavage, while the IgG4 Fc is engineered to minimize Fcγ-receptor binding and immune effector function. The total molecular weight is approximately 63 kilodaltons (Trulicity label) — very large relative to native GLP-1 (about 3.3 kDa).
The molecule is produced in Chinese hamster ovary (CHO) cells via recombinant DNA technology and purified as a sterile solution for subcutaneous injection. It is supplied in a pre-filled single-dose pen (Trulicity pen) at strengths of 0.75 mg, 1.5 mg, 3.0 mg, and 4.5 mg per 0.5 mL. Once-weekly dosing is enabled by the roughly 5-day elimination half-life, which results from a combination of the Fc-mediated FcRn recycling (extending plasma residence) and the large molecular size (slowing renal clearance).
Dulaglutide was first approved by the U.S. FDA in September 2014 for the treatment of type 2 diabetes mellitus in adults, based on the AWARD Phase 3 program. In February 2020, the label was expanded to include cardiovascular risk reduction in adults with T2D who have established cardiovascular disease or multiple cardiovascular risk factors, based on the REWIND trial — notably, the first GLP-1 CV outcomes trial to include a majority (68%) of participants without established CVD at baseline. In September 2020, the FDA approved two higher doses (3.0 mg and 4.5 mg weekly), based on the AWARD-11 trial, for additional glycemic control (Drugs@FDA).
In the broader GLP-1 landscape of 2026, dulaglutide sits at a specific point in the efficacy/tolerability/convenience trade-off: slightly less potent than semaglutide for HbA1c lowering and weight loss, meaningfully less potent than tirzepatide (the GIP/GLP-1 co-agonist), but delivered via an arguably more user-friendly single-dose pen and with cardiovascular benefit established in a primary-prevention-enriched population (REWIND). It is not FDA-approved for obesity as a standalone indication; Eli Lilly advanced tirzepatide (Zepbound) as its obesity product rather than pursuing a Trulicity obesity label.
Mechanism of Action
Dulaglutide activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells (Trulicity label). In cells, rodents and monkeys it kept native GLP-1's effects with a longer half-life, and in monkeys one dose raised glucose-dependent insulin secretion for up to a week (Glaesner et al., 2010); in people its half-life is about 5 days (Trulicity label).
- Glucose-dependent insulin secretion — It raises cAMP in beta cells, leading to glucose-dependent insulin release; first- and second-phase insulin secretion rose vs placebo in people with type 2 diabetes. In the trials, hypoglycemia was more frequent when dulaglutide was combined with a sulfonylurea or insulin than with drugs that do not stimulate insulin release (Trulicity label).
- Glucagon suppression — It reduces glucagon secretion: in a monotherapy trial, fasting glucagon fell 1.71 and 2.05 pmol/L from baseline on 0.75 and 1.5 mg. In a clinical pharmacology study, 1.5 mg lowered fasting glucose 25.6 mg/dL and 2-hour post-meal glucose 59.5 mg/dL vs placebo (Trulicity label).
- Delayed gastric emptying — It delays gastric emptying; the delay grows with dose, is softened by stepping the dose up, and is largest after the first dose, shrinking with later doses (Trulicity label).
- Appetite and weight — In diabetic mice, twice-weekly dosing for 4 weeks lowered weight (Glaesner et al., 2010); in people, decreased appetite was a common side effect, in 4.9% and 8.6% on 0.75 and 1.5 mg vs 1.6% on placebo (Trulicity label).
- Cardiovascular effects — In REWIND, 9,901 adults with type 2 diabetes with or without previous cardiovascular disease, major adverse cardiovascular events fell 12% vs placebo (HR 0.88) over a median 5.4 years (Gerstein et al., 2019). Of its components, non-fatal stroke differed most (HR 0.76, 95% CI 0.61–0.95) and non-fatal heart attack least (HR 0.96, 0.79–1.16); the label lists these descriptively, not as tested results (Trulicity label).
- Renal effects — In an exploratory REWIND analysis, the composite renal outcome (new macroalbuminuria, a sustained eGFR decline of 30% or more, or chronic renal replacement therapy) occurred less often on dulaglutide (HR 0.85), mainly through less new macroalbuminuria (HR 0.77) (Gerstein et al., 2019; PMID 31189509).
- IgG4 Fc fusion pharmacology — Each of its two chains joins a GLP-1 analog to the Fc portion of a modified human IgG4 heavy chain, altered where it would bind high-affinity Fc receptors and form half-antibodies (Trulicity label). The fusion gave a half-life of 1.5–2 days in rats and monkeys (Glaesner et al., 2010) and about 5 days in people (Trulicity label).
- What it does not do — The label describes dulaglutide only as a GLP-1 receptor agonist and names no other receptor target (Trulicity label).
What the Research Shows
Dulaglutide's evidence base is built on the AWARD Phase 3 program (eleven numbered trials), the REWIND cardiovascular outcomes trial, and an expanding set of real-world and head-to-head studies.
- AWARD-1 (Wysham 2014, Diabetes Care; PMID 24879836) — Dulaglutide 1.5 mg or 0.75 mg weekly vs exenatide twice-daily vs placebo, with metformin and pioglitazone background. Dulaglutide 1.5 mg superior to exenatide for HbA1c reduction at 26 weeks.
- AWARD-2 (Giorgino 2015, Diabetes Care; PMID 26089386) — Dulaglutide vs insulin glargine, both added to metformin + glimepiride. Dulaglutide 1.5 mg non-inferior and then superior to glargine for HbA1c reduction at 52 weeks with lower hypoglycemia and weight loss vs weight gain.
- AWARD-3 (Umpierrez 2014, Diabetes Care; PMID 24842985) — Dulaglutide monotherapy vs metformin. Dulaglutide 1.5 mg superior to metformin for HbA1c reduction at 26 weeks.
- AWARD-5 (Nauck 2014, Diabetes Care; PMID 24742660) — Dulaglutide vs sitagliptin, both added to metformin. Dulaglutide superior at 52 weeks.
- AWARD-6 (Dungan 2014, Lancet; PMID 25018121) — Dulaglutide 1.5 mg vs liraglutide 1.8 mg daily, both added to metformin. Dulaglutide non-inferior on HbA1c reduction at 26 weeks. Established head-to-head parity with liraglutide.
- AWARD-7 (Tuttle 2018, Lancet Diabetes Endocrinol; PMID 29910024) — Dulaglutide vs insulin glargine in patients with moderate-to-severe CKD. Dulaglutide non-inferior for HbA1c; beneficial renal profile. Informed dosing in CKD populations.
- AWARD-11 (Frias 2021, Diabetes Care; PMID 33397768) — Dose-response trial: dulaglutide 1.5, 3.0, and 4.5 mg weekly, with metformin background. Dose-dependent additional HbA1c reduction and weight loss at 3.0 and 4.5 mg; tolerability similar across doses. Basis for the 2020 FDA approval of 3.0 and 4.5 mg doses.
- REWIND (Gerstein 2019, Lancet; PMID 31189511) — Double-blind, randomized, placebo-controlled CV outcomes trial. 9,901 adults with T2D plus either established CVD or CV risk factors. Median follow-up 5.4 years. Primary endpoint (first occurrence of MACE — CV death, nonfatal MI, nonfatal stroke): HR 0.88 (95% CI 0.79–0.99, P=0.026). 68% of participants had no established CVD at baseline — notable because most prior GLP-1 CV outcome trials enrolled almost exclusively secondary-prevention populations.
- REWIND renal outcomes (Gerstein 2019, Lancet; PMID 31189509) — Exploratory analysis. Composite renal outcome (new macroalbuminuria, sustained eGFR decline ≥30%, renal replacement): HR 0.85 (95% CI 0.77–0.93, P=0.0004). Favors dulaglutide.
- REWIND cognitive outcomes (Cukierman-Yaffe 2020, Lancet Neurol; PMID 32562683) — Exploratory analysis. The cognitive outcome did not differ significantly (HR 0.93, 95% CI 0.85–1.02, P=0.11); after post-hoc adjustment for baseline scores, HR 0.86 (0.79–0.95). The authors write that dulaglutide “might” reduce cognitive impairment.
- SUSTAIN-7 (not dulaglutide, but relevant) — Head-to-head semaglutide vs dulaglutide. Semaglutide 1.0 mg weekly superior to dulaglutide 1.5 mg for both HbA1c reduction and weight loss. This result, combined with tirzepatide's superior efficacy, has gradually shifted market share.
- Limitations — Dulaglutide has not been tested as an obesity monotherapy; it is not FDA-approved for that indication. Weight loss in the AWARD trials averaged 2–5 kg — clinically meaningful for T2D but modest vs semaglutide 2.4 mg (approximately 15%) or tirzepatide (approximately 20%).
Dulaglutide is FDA-approved, and its cardiovascular outcomes trial, REWIND, enrolled mostly people without established cardiovascular disease (Gerstein et al., 2019; Trulicity label). Head to head, semaglutide 1.0 mg lowered HbA1c and weight more than dulaglutide 1.5 mg (Pratley et al., 2018). Dulaglutide is not approved for weight loss (Trulicity label).
Human Data
The human evidence base is exceptionally large by any standard, and particularly so compared to most compounds on this database.
- AWARD Phase 3 program (AWARD 1 through AWARD 11) — Eleven randomized controlled trials covering dulaglutide monotherapy, combinations with metformin/sulfonylurea/insulin/SGLT2 inhibitor background, head-to-head vs exenatide, glargine, sitagliptin, liraglutide, and sitagliptin, plus dose-finding at 3.0 and 4.5 mg. The program collectively enrolled more than 10,000 patients.
- REWIND (9,901 patients, 5.4-year median follow-up) — The pivotal CV outcomes trial. Primary MACE reduction (Gerstein et al., 2019); in exploratory analyses, fewer renal outcomes (Gerstein et al., 2019; PMID 31189509) and no significant difference in the primary cognitive outcome (Cukierman-Yaffe et al., 2020).
- Post-marketing pharmacovigilance — More than 10 years of post-marketing safety data since 2014 FDA approval. Thyroid C-cell tumor signal remains rodent-only; human thyroid cancer surveillance has not surfaced a clinical signal of concern.
- Real-world evidence — Large-scale retrospective cohort analyses in Medicare and commercial-payer populations confirming the HbA1c and weight-loss profile seen in trials, with the expected attrition and adherence pattern of chronic injectable therapy.
- Pediatric trial (AWARD-PEDS) — A Phase 3 trial in pediatric T2D led to expanded FDA approval for pediatric patients aged 10 years and older in 2022.
- No obesity-indication trial — Eli Lilly did not pursue a dedicated obesity Phase 3 for dulaglutide; the obesity pipeline at Lilly became tirzepatide (Zepbound) and retatrutide (Phase 3, GLP-1 / GIP / glucagon triagonist).
Reconstitution & Storage
Dulaglutide is supplied as a clear, colorless, sterile solution in a pre-filled single-dose pen, ready to inject; there is nothing to reconstitute (Trulicity label).
| Form | Dose Strength | Storage (Unopened) | Storage (In Use) |
|---|---|---|---|
| Trulicity single-dose pen | 0.75 mg / 0.5 mL | 2–8°C refrigerated, in the original carton to protect from light; not frozen | If needed, up to 30°C (86°F) for a total of 14 days. FDA label (Trulicity, 2026). |
| Trulicity single-dose pen | 1.5 mg / 0.5 mL | 2–8°C refrigerated | Up to 14 days at room temp, not above 30°C. FDA label (Trulicity, 2026). |
| Trulicity single-dose pen | 3.0 mg / 0.5 mL | 2–8°C refrigerated | Up to 14 days at room temp, not above 30°C. FDA label (Trulicity, 2026). |
| Trulicity single-dose pen | 4.5 mg / 0.5 mL | 2–8°C refrigerated | Up to 14 days at room temp, not above 30°C. FDA label (Trulicity, 2026). |
- Pre-filled pen — Each pen holds one dose and is used once; the instructions for use send the used pen straight to an FDA-cleared sharps disposal container, not household trash (Trulicity label).
- Temperature stability — The label lists refrigeration at 2–8°C, says not to freeze the pen and not to use one that has been frozen, and recommends the original carton to protect it from light (Trulicity label).
- Room-temperature window — If needed, each pen can be kept at room temperature, not above 30°C (86°F), for a total of 14 days (Trulicity label).
- Injection technique — The pen instructions list the abdomen or thigh, or the back of the upper arm when another person gives the injection, with a different site each week. The clear base is placed flat and firmly on the skin, the lock ring turned and the green button pressed; the base stays on the skin until a second click, about 5–10 seconds later, when the needle retracts (Trulicity label).
- Administration day — Once a week on the same day, at any time of day, with or without food; the day can be changed if the last dose was at least 3 days earlier. A missed dose is taken as soon as possible if at least 3 days (72 hours) remain before the next scheduled dose; with less than 3 days left, it is skipped and the next dose taken on the usual day (Trulicity label).
- Inspection — The label describes a clear, colorless solution and says not to use it if particles or coloration are seen; the pen instructions add a cloudy solution and a pen dropped on a hard surface to that list (Trulicity label).
Side Effects & Risks
Dulaglutide's most common side effects are gastrointestinal: in the label's pool of placebo-controlled trials they occurred in 32% on 0.75 mg and 41% on 1.5 mg vs 21% on placebo (Trulicity label), and in AWARD-1 they were mostly mild to moderate and transient (Wysham et al., 2014).
- Gastrointestinal (most common) — In the label's placebo-controlled pool, on 0.75 and 1.5 mg vs placebo: nausea 12.4% and 21.1% vs 5.3%, diarrhea 8.9% and 12.6% vs 6.7%, vomiting 6.0% and 12.7% vs 2.3%, abdominal pain 6.5% and 9.4% vs 4.9%, decreased appetite 4.9% and 8.6% vs 1.6%, constipation 3.9% and 3.7% vs 0.7%. These side effects led 1.3% and 3.5% to stop, vs 0.2% on placebo, and severe ones occurred in 2.2% and 4.3% vs 1.4%; the label does not recommend dulaglutide in severe gastroparesis and sets its dose steps to reduce the risk (Trulicity label). In AWARD-11, nausea occurred in 13.4%, 15.6% and 16.4% on 1.5, 3 and 4.5 mg (Frias et al., 2021), and in SUSTAIN 7 gastrointestinal disorders were the most common reason for stopping dulaglutide (Pratley et al., 2018).
- Injection site reactions — Reactions such as rash or redness at the site were reported in 0.5% of adults on dulaglutide vs 0.0% on placebo, and in about 4% of children vs 2.0% on placebo (Trulicity label).
- Pancreatitis (rare but serious) — Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing cases, has been seen with GLP-1 receptor agonists, dulaglutide included. In the original registration trials, adjudication confirmed 5 cases on dulaglutide (1.4 per 1,000 patient-years) vs 1 on non-incretin comparators (0.88); in AWARD-11 it occurred in 0.2%, 0.3% and 0.5% on 1.5, 3 and 4.5 mg. The label calls for watching for persistent or severe abdominal pain, which may spread to the back, and for stopping dulaglutide if pancreatitis is suspected (Trulicity label).
- Thyroid C-cell tumors (boxed warning) — In a 2-year rat study, dulaglutide caused a dose- and duration-dependent rise in thyroid C-cell tumors (adenomas and carcinomas) at 3 or more times the human exposure at 4.5 mg a week; a 6-month study in transgenic mice found none. Whether it causes these tumors, including medullary thyroid carcinoma (MTC), in people is unknown; one MTC case occurred in a trial patient whose calcitonin was about 8 times the upper limit of normal before treatment. It is contraindicated with a personal or family history of MTC or with multiple endocrine neoplasia syndrome type 2 (MEN 2), and the label lists a neck mass, trouble swallowing, shortness of breath or persistent hoarseness as possible symptoms (Trulicity label).
- Hypoglycemia — Uncommon without insulin or a sulfonylurea: glucose below 54 mg/dL occurred in 0.3–0.7% on dulaglutide with metformin over 26 weeks, vs 20–21% with a sulfonylurea over 78 weeks and 69–77% with mealtime insulin over 52 weeks. The label warns that an insulin secretagogue or insulin raises the risk, including severe hypoglycemia, and that lowering their dose may be needed (Trulicity label).
- Gallbladder disease — Gallstones and cholecystitis have been reported in GLP-1 receptor agonist trials and after approval. In REWIND, gallstones occurred at 0.62 vs 0.56 per 100 patient-years on placebo, and serious acute cholecystitis in 0.5% vs 0.3%; the label calls for gallbladder studies if gallstones are suspected (Trulicity label).
- Acute kidney injury — Reported after approval with GLP-1 receptor agonists including dulaglutide, in some cases needing hemodialysis, mostly in people dehydrated by nausea, vomiting or diarrhea; the label calls for monitoring kidney function in such patients and for advising them to take precautions against fluid loss (Trulicity label).
- Diabetic retinopathy complications — In REWIND they occurred in 1.9% on dulaglutide vs 1.5% on placebo: 8.5% vs 6.2% in people with a history of retinopathy, 1% vs 1% in those without. The label notes that rapid improvement in glucose control has been linked to temporary worsening of retinopathy, and calls for monitoring patients with a history of it (Trulicity label).
- Hypersensitivity reactions — Systemic reactions, sometimes severe (such as severe hives, widespread rash, or facial or lip swelling), occurred in 0.5% of adults in the trials, and anaphylaxis and angioedema have been reported after approval. The label directs stopping dulaglutide if a reaction occurs, and it is contraindicated after a serious one (Trulicity label).
- Pregnancy and lactation — Human data are too limited to judge the risk. Fetal harm occurred in rabbits at 5 times, and in rats at 6 or more times, the human exposure at 4.5 mg a week, alongside lower maternal food intake and weight. There are no data on dulaglutide in human milk. The label reserves use in pregnancy for when the potential benefit justifies the potential risk to the fetus, and sets no interval for stopping before conception (Trulicity label).
- Drug interactions — Dulaglutide slows stomach emptying and so may slow the absorption of oral drugs; the delay is largest after the first dose. At 1.5 mg it did not change the absorption of the oral drugs tested to a clinically relevant degree, and experience at 3 and 4.5 mg is limited. The label calls for monitoring drug levels of oral drugs with a narrow therapeutic index, such as warfarin, and presumes dulaglutide is broken down into amino acids by general protein catabolism (Trulicity label).
- Immunogenicity — In the adult glycemic trials, 64 of 3,907 people on dulaglutide (1.6%) developed anti-drug antibodies, 34 (0.9%) of them neutralizing, with no clinically significant effect on drug levels, safety or effectiveness over 24–104 weeks (Trulicity label).
Bloodwork & Monitoring
The Trulicity label sets no routine lab schedule. What the label lists, and what the trials measured:
- HbA1c — The primary end point of the AWARD trials, read at 26, 36 or 52 weeks (Umpierrez et al., 2014; Frias et al., 2021; Nauck et al., 2014).
- Blood glucose with insulin or a sulfonylurea — The label notes a higher risk of hypoglycemia, including severe hypoglycemia, when dulaglutide is used with an insulin secretagogue or insulin, says lowering their dose may be needed, and calls for teaching patients its signs (Trulicity label).
- Weight — In the trials, weight fell 1.4 kg on 0.75 mg and 2.3 kg on 1.5 mg over 26 weeks as the only diabetes drug (Trulicity label), and 3.0 kg on 1.5 mg vs 4.6 kg on 4.5 mg over 36 weeks in AWARD-11 (Frias et al., 2021).
- Renal function (eGFR, urine albumin-to-creatinine ratio) — The label calls for monitoring kidney function in patients with side effects that could deplete fluids, especially when the dose is started or raised, and in patients with kidney impairment who report severe stomach or bowel side effects; it sets no dose change for kidney impairment (Trulicity label). REWIND measured eGFR and urine albumin-to-creatinine ratio every 12 months (Gerstein et al., 2019; PMID 31189509).
- Thyroid symptoms (counseling-based, not routine lab) — The label calls routine serum calcitonin or thyroid ultrasound monitoring of uncertain value for finding medullary thyroid cancer early, and lists a neck mass, trouble swallowing, shortness of breath or persistent hoarseness as possible symptoms of thyroid tumors (Trulicity label).
- Pancreatic symptoms — The label calls for watching for signs of acute pancreatitis after starting, such as persistent or severe abdominal pain that may spread to the back. Lipase and pancreatic amylase rose 14–20% on average from baseline in the trials, vs up to 3% on placebo (Trulicity label).
- Retinopathy screening — The label calls for monitoring patients with a history of diabetic retinopathy for its progression (Trulicity label).
- Pregnancy — The label advises patients to tell their provider if they are pregnant or plan to become pregnant; it sets no interval for stopping before conception (Trulicity label).
Commonly Stacked With
Metformin was the background drug in most of the AWARD trials on this page — AWARD-1, -2, -5, -6 and -11 (Wysham et al., 2014; Giorgino et al., 2015; Nauck et al., 2014; Dungan et al., 2014; Frias et al., 2021) — and 81% of REWIND participants took it at baseline (Trulicity label). In the label's interaction studies, dulaglutide 1.5 mg did not change metformin absorption to a clinically relevant degree (Trulicity label).
The ADA's 2024 Standards of Care say an SGLT2 inhibitor and a GLP-1 receptor agonist “may be considered” together for their complementary cardiovascular and kidney benefits (American Diabetes Association, 2024). In the label's 24-week trial in 423 adults already on an SGLT2 inhibitor (96% also on metformin), dulaglutide 0.75 or 1.5 mg lowered HbA1c 1.2–1.3 points vs 0.6 on placebo, and weight 2.5–2.9 kg vs 2.0 kg (Trulicity label).
When insulin is used, the ADA's 2024 Standards of Care recommend combining it with a GLP-1 receptor agonist, and say insulin dosing should be reassessed when one is added (American Diabetes Association, 2024). In the label's 28-week trial of dulaglutide 1.5 mg added to insulin glargine in 300 adults, the glargine dose was cut 20% at the start in those with HbA1c below 8.0%; HbA1c fell 1.4 points vs 0.7 on placebo, and weight fell 1.3 kg vs a 0.8 kg gain (Trulicity label).
Alternatives, not a pair. Head to head over 40 weeks in 1,201 adults with type 2 diabetes on metformin, semaglutide 1.0 mg lowered HbA1c 1.8 points vs 1.4 on dulaglutide 1.5 mg, and weight 6.5 kg vs 3.0 kg (Pratley et al., 2018).
Tested together in people: none published · Read the receipt →
REWIND added dulaglutide to usual care: at baseline 66% of participants took a statin, 82% an ACE inhibitor or angiotensin receptor blocker and 52% aspirin, and investigators were to adjust treatment to local targets for glucose, lipids and blood pressure during the trial (Trulicity label).
The older, three-times-daily amylin drug. Together only in one case report: a woman with type 1 diabetes and obesity lost a further 12.8 kg (14.0%) over 7 months after adding dulaglutide and pramlintide to topiramate (2023). No trial.
Tested together in people: 1 case report (2023) (Wong et al., 2023) · Read the receipt →
Legal Status
Dulaglutide (Trulicity®) is FDA-approved. The original approval (September 2014) was for improving glycemic control in adults with type 2 diabetes. The label was expanded in February 2020 to include cardiovascular risk reduction in adults with T2D with established CVD or multiple CV risk factors (based on the REWIND trial). In September 2020, the FDA approved the 3.0 mg and 4.5 mg weekly doses based on AWARD-11 (Drugs@FDA). In 2022, the pediatric indication was added for patients aged 10 years and older.
Dulaglutide is approved by the European Medicines Agency (CHMP positive opinion September 2014, EU marketing authorisation November 2014; EMA EPAR), Health Canada, TGA (Australia), PMDA (Japan), and most major global regulators. It is on the WHO Model List of Essential Medicines.
Dulaglutide is not a controlled substance, is not on the FDA Category 2 Bulk Drug Substances list, and was not among the 12 peptides FDA removed from Category 2 in April 2026 (FDA 503A categories list, April 22, 2026). As an FDA-approved biologic produced by Eli Lilly under strict GMP, it exists entirely within the conventional pharmaceutical regulatory framework — prescription-only, distributed through licensed pharmacies, not eligible for 503A/503B compounding.
WADA: GLP-1 agonists are not specifically named on the WADA Prohibited List as of the 2026 edition. Dulaglutide is used in clinical practice by athletes with T2D when medically indicated.
Dulaglutide is available as branded Trulicity by prescription in the United States and globally. It is distributed by Eli Lilly through licensed pharmacies; there is no generic or biosimilar dulaglutide as of April 2026 (biosimilars for complex Fc-fusion biologics face a longer development runway than for smaller peptide hormones). Manufacturer patient-assistance programs exist for eligible patients, and formulary placement varies widely by payer.
Dulaglutide is not compoundable in the United States under current FDA rules. Unlike semaglutide and tirzepatide, dulaglutide has no "compounded analog" shortage history because supply of Trulicity has been relatively stable. The large Fc-fusion molecule is also substantially more difficult to synthesize in a 503A compounding pharmacy context than a smaller peptide like semaglutide — practical compounding of dulaglutide is not commercially viable.
Dulaglutide was not among the 12 peptides FDA removed from Category 2 in April 2026 (FDA 503A categories list, April 22, 2026). Those removals concerned Category 2 peptide bulk substances (BPC-157, injectable GHK-Cu, KPV and others in the compounding-peptide space), not the FDA-approved biologic space where Trulicity resides.
Estimated pricing as of April 2026. Actual costs vary by provider, location, insurance, and prescription status. Kalios does not sell compounds.
Next Steps
References
- Dungan KM, Povedano ST, Forst T, González JG, Atisso C, Sealls W, Fahrbach JL. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014 Oct 11;384(9951):1349-57. PMID: 25018121.
- Wysham C, Blevins T, Arakaki R, Colon G, Garcia P, Atisso C, Kuhstoss D, Lakshmanan M. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014 Aug;37(8):2159-67. PMID: 24879836.
- Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). Diabetes Care. 2015;38(12):2241-9. PMID: 26089386.
- Umpierrez G, Tofé Povedano S, Pérez Manghi F, Shurzinske L, Pechtner V. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014 Aug;37(8):2168-76. PMID: 24842985.
- Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, Milicevic Z. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014 Aug;37(8):2149-58. PMID: 24742660.
- Tuttle KR, Lakshmanan MC, Rayner B, Busch RS, Zimmermann AG, Woodward DB, Botros FT. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018 Aug;6(8):605-617. PMID: 29910024.
- Frias JP, Bonora E, Nevarez Ruiz L, Li YG, Yu Z, Milicevic Z, Malik R, Bethel MA, Cox DA. Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11). Diabetes Care. 2021 Mar;44(3):765-773. PMID: 33397768.
- Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Rydén L, et al; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):121-130. PMID: 31189511.
- Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Botros FT, Riddle MC, Rydén L, et al. Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):131-138. PMID: 31189509.
- Cukierman-Yaffe T, Gerstein HC, Colhoun HM, Diaz R, García-Pérez LE, Lakshmanan M, Bethel A, Xavier D, Probstfield J, Riddle MC, et al. Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial. Lancet Neurol. 2020 Jul;19(7):582-590. PMID: 32562683.
- Pratley RE, Aroda VR, Lingvay I, Lüdemann J, Andreassen C, Navarria A, Viljoen A; SUSTAIN 7 investigators. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018 Apr;6(4):275-286. PMID: 29397376.
- Glaesner W, Vick AM, Millican R, Ellis B, Tschang SH, Tian Y, Bokvist K, Brenner M, Koester A, Porksen N, Etgen G, Bumol T. Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY2189265, an Fc fusion protein. Diabetes Metab Res Rev. 2010;26(4):287-96. PMID: 20503261. (Molecular engineering of dulaglutide.)
- FDA. Trulicity (dulaglutide) Prescribing Information. Eli Lilly and Company, Indianapolis, IN. Current version 2024/2025.
- European Medicines Agency. Trulicity (dulaglutide) EPAR — Assessment Report. EMA/CHMP/578928/2014. (Original EU approval documentation.)
- American Diabetes Association. Standards of Care in Diabetes — 2024/2025. Pharmacologic Approaches to Glycemic Treatment. Diabetes Care 2024;47(Suppl 1).
- FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (503A categories list), versions updated April 15, April 22 and May 14, 2026. fda.gov/media/94155/download. Read October 3, 2026. (Notice that 12 peptides would leave Category 2 because their nominations were withdrawn; their removal; GHK-Cu, except injectable, back in Category 1.)
- Eli Lilly and Company. Trulicity (dulaglutide) injection prescribing information. DailyMed set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309 (version effective June 16, 2026). dailymed.nlm.nih.gov. Read October 4, 2026.
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Tested together in people
Checked 18 Oct 2026